Revocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater

Resumen

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to May 25, 2005. The revocation does not affect the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) recovered on or after May 25, 2005. The rule is being finalized because these regulations are obsolete or no longer necessary to achieve public health goals.